Through 48 weeks of follow up, 47 patients (90.4 percent) experienced one or more TEAEs during the study; and 24 patients (46.2 percent) had TEAEs that were possibly or probably related to the study drug, most being mild or moderate in intensity. A total of 278 TEAEs were reported, with the following reported in at least five subjects: seizure, upper respiratory tract infection, somnolence, anemia, diarrhea and pyrexia. Of the 37 serious adverse events reported, three were considered possibly related to the study drug: moderate change in seizure presentation; moderate ataxia; and worsening seizure exacerbation.
December 04, 2018 06:00 ET | Source: INSYS Therapeutics, Inc. INSYS Therapeutics, Inc.
Chandler, Arizona, UNITED STATES
PHOENIX, Dec. 04, 2018 (GLOBE NEWSWIRE) — Pharmaceutical-grade cannabidiol (CBD) oral solution made by INSYS Therapeutics, Inc. (NASDAQ: INSY), a leader in the development, manufacture and commercialization of pharmaceutical cannabinoids and spray technology, was generally well-tolerated—even at high doses—as an investigational treatment for refractory pediatric epilepsy, according to new clinical data from a long-term safety study presented yesterday at the American Epilepsy Society (AES) 2018 annual meeting.
Safety assessments included treatment-emergent adverse events (TEAEs), electrocardiograms, physical and neurologic exams and lab tests. Additional assessments included Clinical Global Impression of Severity (CGI-S) and Clinical Global Impression of Improvement (CGI-I) by investigator and caregiver at baseline (CGI-S only), Week 4, 8, 12, 24 and 36, final visit and follow-up visit.
Dr. Wheless presented the results of this multicenter, open-label, flexible-dose study (INS011-14-030) during AES Poster Session 3. The presentation (Abstract 3.294) reported safety data from 52 patients (nine infants, 26 children and 17 adolescents) from 11 U.S. clinical sites.
A total of 45 patients completed the study, which was designed to assess the long-term safety and tolerability of the company’s proprietary formulation of CBD oral solution as adjunctive treatment for pediatric patients (ages 1–17 years old) with treatment-resistant epilepsy. Patients received doses of CBD oral solution at 10, 20, or 40 mg/kg/day (in two divided doses) for approximately 48 weeks, with dose changes at the investigators’ discretion. Defined as the dose with the longest duration, the mean modal dose was 24.42 mg/kg/day (higher in infants than in children and adolescents); and the mean total duration of study drug was 311.1 days (with a maximum exposure of 384 days).
INSYS Therapeutics is a specialty pharmaceutical company that develops and commercializes innovative drugs and novel drug delivery systems of therapeutic molecules that improve patients’ quality of life. Using proprietary spray technology and capabilities to develop pharmaceutical cannabinoids, INSYS is developing a pipeline of products intending to address unmet medical needs and the clinical shortcomings of existing commercial products. INSYS is committed to developing medications for potentially treating addiction to opioids, opioid overdose, epilepsy, and other disease areas with a significant unmet need.
“We have great hope in the potential of our proprietary formulation of pharmaceutical-grade, synthetically manufactured CBD oral solution in combination with vigabatrin to offer greater seizure control to children with infantile spasms,” said Steve Sherman, senior vice president of regulatory affairs for INSYS Therapeutics. “The need for more efficacious and better tolerated products to treat this devastating disorder continues to motivate us to advance this investigational therapy through the clinical and regulatory pathway.”
Chandler, Arizona, UNITED STATES
“We need better treatments for infantile spasms, one of the more severe and dangerous seizure disorders of early childhood,” said Shaun Hussain, M.D., a pediatric neurologist at UCLA Mattel Children’s Hospital and director of its Infantile Spasms Project. “That’s why we’re excited about this pivotal study, which has the potential to reveal a new piece of the treatment puzzle for infantile spasms.”
Pivotal study aims to evaluate safety and efficacy of company’s novel CBD product candidate in rare type of pediatric epilepsy
According to the Infantile Spasms Action Network (ISAN), a collaborative advocacy network of 25 national and international organizations convened by CNF, infantile spasms have an average age of onset of around four months, although in some cases the first seizure occurs as early as one month or as late as two years. In most cases, infantile spasms appear to be slight head drops, which belie the seriousness of the condition. Evidence shows that infantile spasms are a more serious seizure disorder than generalized convulsions.
March 02, 2018 08:30 ET | Source: Insys Therapeutics, Inc. Insys Therapeutics, Inc.
In previous studies, CBD—one of the main molecules in cannabis—has demonstrated sustained clinical benefits in a variety of medically refractory pediatric epilepsies, including infantile spasms, an uncommon condition estimated by the Child Neurology Foundation (CNF) to be diagnosed in about 1,200 children in the United States each year.
PHOENIX, March 02, 2018 (GLOBE NEWSWIRE) — INSYS Therapeutics, Inc. (NASDAQ:INSY), a leader in the development, manufacture and commercialization of pharmaceutical cannabinoids and spray technology, today announced the initiation of a Phase 3 clinical trial to study cannabidiol (CBD) oral solution for the treatment of infantile spasms, a rare type of pediatric epilepsy that occurs in very young children, with the first trial site’s activation.
INSYS Therapeutics recently became a member of ISAN, which hosts an annual awareness and education initiative, Infantile Spasms Awareness Week (ISAW), held Dec. 1–7.
Michael L. Babich, the President and Chief Executive Officer of Insys Therapeutics, commented on the orphan drug designation. “With no cure and persistence of seizures with current antiepileptic medications, the orphan drug designation recognizes the significant, unmet need that exists among children with this severe form of epilepsy and the teams who provide their care," said Babich. "We have the unique opportunity to test a controlled pharmaceutical CBD product for Lennox-Gastaut Syndrome, and our company is committed to advancing cannabinoid therapies that have the potential to provide significant medical benefits to patients across multiple indications. We expect to file an Investigational New Drug Application (IND) for CBD in the second half of 2014.”
Insys has been researching and developing pharmaceutical cannabinoids for seven years, and the company says it will continue to develop new treatments for Dravet Syndrome, which is another rare form of pediatric epilepsy. Insys is also looking to use pharmaceutical CBD to treat other areas, such as glioblastoma, adult epilepsy, chemotherapy-induced peripheral neuropathy, in addition to cocaine, heroin, and opioid addictions.
Insys Therapeutics has announced that it is receiving orphan drug designation for its pharmaceutical cannabidiol (CBD), which is used to treat Lennox-Gastaut Syndrome — a rare form of pediatric-onset epilepsy. The orphan drug designation will allow Insys to gain a seven year period of marketing exclusivity in the U.S. if the drug is ultimately approved by the FDA and put on the market.
Using cannabis-based products for medical purposes has been relatively controversial in political circles, but pharmaceutical companies have been increasingly engaging in the research and development of cannabis based products, especially to treat epilepsy and diseases which cause seizures.